Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

28751–28775 of 40357

HighFDA (Devices)·Z-0295-2017·2016-10-26
Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure
Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.
Product
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0135-2017·2016-10-26
ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise
ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.
Product
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2017·2016-10-26
Windstone Medical Recalls Morris Hysto Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 186 Morris Hysto Pack kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.
Product
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2017·2016-10-26
Windstone Medical Knee Packs Recalled for Potential Sterility Compromise
Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2017·2016-10-26
Olympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions
Olympus is recalling OER-Pro endoscope reprocessors because instructions may incorrectly suggest skipping precleaning steps. Users must conduct manual cleaning.
Product
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0087-2017·2016-10-26
Zimmer Biomet Recalls Uniflex Humeral Nail Guide Pins Due to Packaging Error
Zimmer Biomet is recalling 22 units of Uniflex Humeral Nail guide pins because they may be packaged with the wrong combination of pins, potentially causing surgical delays or injury.
Product
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0125-2017·2016-10-26
X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices
X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.
Product
Calix P PEEK Lumbar System, PLIF Trial
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0156-2017·2016-10-26
Windstone Medical Breast Pack Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Product
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2017·2016-10-26
Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up
Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.
Product
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0207-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0168-2017·2016-10-26
Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.
Product
Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0277-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0234-2017·2016-10-26
Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling Major Lithotomy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2017·2016-10-26
Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters are not operating within the correct pressure pulse specifications.
Product
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0230-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising sterility.
Product
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0237-2017·2016-10-26
Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2017·2016-10-26
Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk
Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2017·2016-10-26
Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0264-2017·2016-10-26
Windstone Medical Recalls Podiatry Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 545 podiatry kits because disposable gloves inside may have splits or holes that compromise sterility.
Product
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0259-2017·2016-10-26
Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 430 Peri GYN surgical kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide

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28751–28775 of 40357